Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities

Chronic Obstructive Pulmonary Disease Clinical Trial

— PICCOPD+  

Official title:

Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648621
• Other study ID #: TEGH001 PIC COPD
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: November 10, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Toronto East General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial Summary

Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• COPD defined as chronic irreversible airflow limitation with FEV1 < lower limit of normal for age as % predicted and a FEV1/FVC ratio < than lower limit of normal (usually 70%) [5]

Plus = 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines*

1. Cardiovascular disease

2. Osteopenia and osteoporosis

3. Glaucoma and cataracts

4. Cachexia and malnutrition

5. Peripheral muscle dysfunction

6. Lung cancer

7. Metabolic syndrome (diabetes mellitus)

8. Depression

9. Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + = 1 other comorbidity

THAT

1. Get admitted to participating hospital; or

2. Present to participating hospital ED; or

3. Have first referral to Respiratory Centre/Respirology team

AND HAVE

1. = 1 ED presentation/hospital admission in previous 12 months

2. = 50 years age

Exclusion Criteria:

1. No access to primary care physician

2. Primary diagnosis of asthma

3. Terminal diagnosis (metastatic disease with a life expectancy of = 6 months)

4. Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination

5. Uncontrolled psychiatric illness

6. Inability to understand, read, and write English

7. No access to a phone

8. Inability to attend follow up at one of the participating sites

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Multiple Comorbidity
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 40 minute standardized education session
40 minute standardized education session based on the Living Well with COPD Patient's Education Tool on study enrolment to assess and improve understanding of disease and ability to monitor symptoms and recognize exacerbation
• Individualized action plan
Individualized action plan using the Living Well with COPD template with patient individualized modification to address management strategies for exacerbation of comorbidity developed during the initial 40 minute session with case manager.
• Individualized care plan
Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
• Standardized reinforcement/motivational interviewing and action plan teach-back sessions
Standardized reinforcement/motivational interviewing and action plan teach-back sessions based on Living Well with COPD modules as well as assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions) (telephone script; NOTE: case managers will make up to 3 attempts to contact participants during each week of the 12 weeks of weekly phone calls before determining inability to contact the participant for that week.
• Tele-home monitoring
Tele-home monitoring of SpO2, weight, dyspnea, sputum quantity and characteristics, and general well-being for maximum of 6 months. Inclusion criteria for tele-home monitoring: a. compatible phone line b. patient consent c. patient or caregiver demonstrated ability to use monitoring equipment d. patient unable to attend outpatient/community appointments for assessment and monitoring because of environmental barriers to access (e.g. physician's office only accessible by stairs) e. severe dyspnea on activities of daily living (Medical Research Council Questionnaire for Assessing Severity of Breathlessness [MRC] Class 4 & 5 or modified MRC [mMRC] 3 & 4) f. frequent ED visits (> 2) in last 12 months 5. 12 weeks of clinical stability with no ED visits.
• Coordinated and improved communication
Coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and Community Care Access Centres (CCACs) facilitated by the case manager. This will include phone contact by case manager to family physicians and CCAC case manager if applicable after initial enrollment, education session and development of action plan, then monthly to report general status as well as after subsequent ED presentations/hospital admissions
• Priority access
Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
• Dictated patient summary
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
• in-hospital rehabilitation/self-management program
Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are: have had a recent exacerbation, but are now clinically stable; symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment; have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and have sufficient motivation to participate.
• Smoking cessation
Referral to a smoking cessation program (as applicable)
• Action plan Respirologist
Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
• Web based self management materials
Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)

Locations

Country	Name	City	State
Canada	Southlake Regional Heath Centre	Newmarket	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Toronto East General Hospital	Ontario Ministry of Health and Long Term Care, Southlake Regional Health Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to chronic disease management measures	smoking cessation status (if applicable), influenza and pneumonia vaccination, up-to-date documented action plan, electronic medication reconciliation	at 1 year	No
Primary	The number of ED presentations		1 year after randomization.	No
Secondary	Hospital admission rates		1 year after randomization	No
Secondary	Number of hospitalized days over 1 year		At one year after randomization	No
Secondary	Time to death		During 12 months of intervention	Yes
Secondary	COPD severity measured by the BODE index	The BODE Index is a simple grading system for COPD comprising the Six Minute Walk Distance (6MWD), the Medical Research Council Dyspnea Scale (MMRC) and body mass index (BMI).	at baseline, 6 months and 1 year	No
Secondary	Change in health-related quality of life	Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS)	baseline at 90 days, 6 months and 1 year	No
Secondary	Change in COPD self-efficacy scale	The COPD SES provides items with sufficient complexity in relation to the specific situation of managing with COPD. The CSES consists of Likert scale with 5 responses from "very confident" to "not at all confident" scoring 5 to 1 with 5 representing higher self-efficacy.	baseline at 90 days, 6 months and 1 year	No
Secondary	Patient satisfaction using the CSQ8		90 days, 6 months and 1 year	No
Secondary	Caregiver impact (Caregiver Impact Scale)	This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale.	at baseline, 6 months and 1 year	No